ONBREZ BREEZHALER

This brand name is authorized in Australia, Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug ONBREZ BREEZHALER contains one active pharmaceutical ingredient (API):

1	Indacaterol UNII 2JEC1ITX7R - INDACATEROL MALEATE
	Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action.
	Read more about Indacaterol

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ONBREZ BREEZHALER Inhalation powder, hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
R03AC18	Indacaterol	R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AC Selective beta-2-adrenoreceptor agonists
Discover more medicines within R03AC18

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	5134F, 5137J
CA	Health Products and Food Branch	02376938
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	05742491, 05742516, 06424480, 06424497, 06573814, 07550057, 07550063, 07713594, 07713654, 07769904, 07769927, 08794407, 09060587, 09488492, 11525131, 12739029, 12739041, 12739058, 16626032, 16626049, 17936970
EE	Ravimiamet	1452158, 1452169, 1452170, 1452181, 1452192, 1452204, 1452215, 1452226, 1452237, 1452248
ES	Centro de información online de medicamentos de la AEMPS	09593002, 09593007
FI	Lääkealan turvallisuus- ja kehittämiskeskus	075031, 075042, 075064, 075075
FR	Base de données publique des médicaments	62036213, 67084265
GB	Medicines & Healthcare Products Regulatory Agency	173000, 173009, 375263, 375268, 381572, 381574
HK	Department of Health Drug Office	60179, 60180
IE	Health Products Regulatory Authority	37611, 37612, 37635, 37636, 42843, 42891
IL	מִשְׂרַד הַבְּרִיאוּת	6656, 6657
IT	Agenzia del Farmaco	039664014, 039664026, 039664038, 039664040, 039664053, 039664065, 039664077, 039664089, 039664091, 039664103
JP	医薬品医療機器総合機構	2259710G1020
LT	Valstybinė vaistų kontrolės tarnyba	1052400, 1052401, 1052402, 1052403, 1052404, 1052405, 1052406, 1052407, 1052408, 1052409
NL	Z-Index G-Standaard, PRK	92347, 92355
NZ	Medicines and Medical Devices Safety Authority	14709, 14710
PL	Rejestru Produktów Leczniczych	100217883, 100217890
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64463001, W64463002, W64463003, W64463004, W64463005, W64464001, W64464002, W64464003, W64464004, W64464005
SG	Health Sciences Authority	13988P, 13989P
TN	Direction de la Pharmacie et du Médicament	10283331
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504550405, 8699504550450
ZA	Health Products Regulatory Authority	44/10.2.1/0544